Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-3305-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

Product Classification:

Class II

Date Initiated: August 21, 2024

Date Posted: October 9, 2024

Recall Number: Z-3305-2024

Event ID: 95259

Reason for Recall:

Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

Status: Ongoing

Product Quantity: 9783 kits

Code Information:

UDI-DI: Material Number 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated